Hemofiltration in Acute Ischemic Stroke

NCT03454867 | Completed

• 1 other identifier: Hemoinstroke
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ischemic stroke is accompanied by a three to four hundred percent increase in the brain's extracellular fluid (ECF) and cerebrospinal fluid (CSF) concentration of glutamate, which diffuses and damages surrounding neurons. In this study we tested our hypothesis that blood glutamate levels can be reduced by hemofiltration, resulting in increased extracellular clearance of glutamate and attenuated neurodegeneration, and that decreased blood glutamate levels can provide significant neuroprotection against stroke-associated neurodegeneration, dysfunction and death. Our primary outcome of interest was to assess safety of hemofiltration in acute ischemic stroke patients.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Safety monitoring for adverse events

  The patients were screened continuously for the following adverse events: death, bleeding disorders, hemorrhagic transformation of acute ischemic stroke, central line-related blood stream infection, cardiac dysrhythmia within 28 days

  28 days

Study Arms (2)

Hemofiltration (treatment)

EXPERIMENTAL

Standard acute ischemic stroke treatment + hemofiltration Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)

Device: Hemofiltration; Procedure: Standard acute ischemic stroke treatment

Control

ACTIVE COMPARATOR

Standard acute ischemic stroke treatment Standard treatment included thrombolytic therapy for eligible candidates (tPA 0,9 mg/kg, max dose 90 mg)

Procedure: Standard acute ischemic stroke treatment

Interventions

Hemofiltration DEVICE

Hemofiltration (treatment)

Standard acute ischemic stroke treatment PROCEDURE

Control; Hemofiltration (treatment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 year-old; both males and females;
• Diagnosis of acute ischemic stroke verified by CT or MRI and moderate to severe disability (NIHSS 5-21 points, GCS \> 4 points and \< 12);
• Able to start hemofiltration treatment within 12 hours of stroke onset.;
• Signed written informed consent in either Kazakh or Russian.

You may not qualify if:

• Age below 18 years or above 75 years;
• Presentation over 12 hours from stroke onset;
• Decompensated coronary heart disease (unstable angina, acute myocardial infarction, heart failure - according to New York or Canadian classification, 3, blood disorders, known coagulopathy, platelet count less than75 000 / mmc;
• Pulmonary edema, shock, hemodynamic instability;
• Intracranial hemorrhage or lesions (brain abscess, tumors);
• Inability to obtain informed consent;
• Pregnancy;
• Contraindications for CT.

Sponsors & Collaborators

• University Medical Center, Kazakhstan: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hemofiltration

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending anesthesiologist & intensivist

Model Details: Hemofiltration protocol. Hemofiltration was started after all enrollment criteria (informed consent, inclusion/exclusion criteria checklists, registration and assignment to treatment arm) had been met . Vascular access was secured by inserting an 11F double lumen catheter (GamCath, Gambro, Germany) into the jugular, femoral or subclavian vein. CVVH (continuous veno-venous hemofiltration) was carried out using a hemofiltration machine (Fresenius Multifiltrate, Germany). In all patients a 1.9 m2 highly permeable cellulose triacetate hemofilter was used (NIPRO UF205, Nissho corporation, Japan). All patients were treated by CVVH with the predilution mode; the blood flow was set at 180 ml/min.

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: March 6, 2018
• Study Start: June 1, 2014
• Primary Completion: January 31, 2015
• Study Completion: January 31, 2015
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share